Drugs Ease Hard-to-Treat Constipation

May 28, 2008 -- Results only now reported from a 12-week clinical trial that
ended nine years ago suggest that a new drug, Resolor, helps people with
chronic constipation.

Meanwhile, promising findings suggest that a new form of naltrexone, a drug
used to block the narcotic effects of opioids in addicts, may relieve the terrible
constipation that afflicts patients who need opioids to control their pain.

The Resolor results appeared only after Johnson & Johnson, which
developed the drug, licensed it to the Belgian firm Movetis NV.

Late or not, the results may be good news to the estimated 15% of Americans
who suffer the straining, bloating, and abdominal discomfort of chronic
constipation.

Resolor "significantly increased the number of spontaneous, complete
bowel movements, reduced the severity of symptoms, and improved the disease-related quality of
life in patients with severe chronic constipation," report Mayo Clinic
researcher Michael Camilleri, MD, and his Movetis colleagues.

Nearly half of the patients receiving Resolor, but only a fourth of the
patients receiving an inactive placebo, averaged at least one complete bowel
movement per week.

None of the patients showed signs of heart problems. That's good news, but
there's reason to need more safety data, says Arthur J. Moss, MD, of the
University of Rochester in New York. Moss' editorial accompanies the Camilleri
report in the May 29 issue of The New England Journal of Medicine.

Resolor is in the same drug family as Propulsid and Zelnorm, both of which
were taken off the market because they caused dangerous heart problems in some
patients. Zelnorm returned to the market with a dire warning on its label, but
was then voluntarily removed from the market by the manufacturer.

"It is not clear why clinical trials with [Resolor] were temporarily
suspended around 2001 or why it took so long to bring this study to
publication," Moss notes. "We simply do not know whether the drug will
[cause serious heart problems] in a small fraction of vulnerable subjects with
a non-life-threatening gastrointestinal disorder."

Moss says more complete data will be needed before the drug should be
brought to market as a treatment for chronic constipation.